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Date Printed: August 23, 2017: 06:10 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-V0000-01

Original Effective Date: 11/15/01

Reviewed: 05/25/17

Revised: 06/15/17

Subject: Prosthetic Eyes and Lens Implants

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Prosthetics are artificial substitutes that replace all or part of a body organ or replace all or part of the function of a permanently inoperative, absent, or malfunctioning body part whether surgically implanted or worn as an anatomic supplement.

The lens of the eye is considered an internal body organ. Prosthetics replacing the lens of an eye include post-surgical lenses used during convalescence from eye surgery in which the lens of an eye was removed.

Scleral contact lenses create an elevated chamber over the cornea that can be filled with artificial tears. The base or haptic is fit over the less sensitive sclera. A scleral contact lens has been proposed to provide optical correction, mechanical protection, relief of symptoms, and facilitation of healing for a variety of corneal conditions. Specifically, the scleral contact lens may neutralize corneal surface irregularities and, by covering the corneal surface in a reservoir of oxygenated artificial tears, function as a liquid bandage for corneal surface disease. This may be called prosthetic replacement of the ocular surface ecosystem (PROSE).

The development of materials with high gas permeability and technologic innovations in design and manufacturing has stimulated the use of scleral lenses. The Boston Ocular Surface Prosthesis™ (Boston Foundation for Sight) is a scleral contact lens that is custom fit using computer-aided design and manufacturing (ie, computerized lathe). Another design is the Jupiter mini-scleral gas permeable contact lens (Medlens Innovations and Essilor Contact Lens). The Jupiter scleral lens is fitted using a diagnostic lens series. The Procornea (Eerbeek) scleral lens was developed in Europe. There are 4 variations of the Procornea: spherical, front-surface toric, back-surface toric, and bitoric. Lenses are cut with submicron lathing from a blank. The Rose K2 XL lens (Menicon, Japan) is a semi-scleral lens.

The Boston Ocular Surface Prosthesis, which is the prosthetic device used in PROSE, reeived premarket approval from the U.S. Food and Drug Administration (FDA) in 1994.

POSITION STATEMENT:

Note: Coverage for prosthetic lenses (lens implants) is subject to the member’s benefit terms, limitations and maximums.

Prosthetic lenses (lens implants) meet the definition of medical necessity when they perform the function of the human lenses in the absence of human lenses due to surgery, injury, disease, or congenital anomaly.

The following may be eligible for coverage:

Corneal rigid contact lenses may be covered when provided for the treatment of keratoconus ICD-10 codes (H18.601 – H18.629, Q13.4).

Gas impermeable scleral contact lenses (V2530) when prescribed as a prosthetic device to support surrounding orbital tissue of a shrunken and sightless eye or when prescribed for the treatment of dry eye (failure of lacrimal gland to produce enough tears).

Rigid gas permeable scleral contact lenses (S0515, V2531) meet the definition of medical necessity for members who have not responded to topical medications or standard spectacle or contact lens fitting, for the following conditions:

• Corneal ectatic disorders (e.g., keratoconus, keratoglobus, pellucid marginal degeneration,

Terrien’s marginal degeneration, Fuchs’ superficial marginal keratitis, postsurgical ectasia);

• Corneal scarring and/or vascularization;

• Irregular corneal astigmatism (e.g., after keratoplasty or other corneal surgery);

• Ocular surface disease (e.g., severe dry eye, persistent epithelial defects, neurotrophic keratopathy, exposure keratopathy, graft vs host disease, sequelae of Stevens Johnson syndrome, mucus membrane pemphigoid, postocular surface tumor excision, postglaucoma filtering surgery) with pain and/or decreased visual acuity.

Use of a rigid gas permeable scleral lenses for any other condition do not meet the definition of medical necessity.

There are three categories of intraocular lenses:

  1. Anterior chamber lenses
  1. Iris supported lenses
  2. Posterior chamber lenses.

One pair of lenses (or frames with lenses), any type, is covered as a prosthesis if an intraocular lens has been implanted.

Prosthetic eyes (V2623, V2624, V2625, V2626, V2627, and V2629) for replacement of the human organ meets the definition of medical necessity when prescribed by a physician (M.D. or D.O.) or by an optometrist (O.D.).

Replacement and Repair

Replacement of eye prostheses is eligible for coverage when the replacement is required due to one of the following:

*Replacements resulting from loss or irreparable damage may be reimbursed without a physician's order when coverage requirements were met for the original prosthesis.

**Replacements resulting from wear or a change in the patient's condition must be supported by a current physician's order.

Replacement of frames must be documented for medical necessity.

Reimbursement for the repair of eye prostheses is not to exceed the cost of replacement.

Prosthetic lenses are not eligible for coverage when provided for correction of ordinary refractive errors in the non-diseased eye. Based on the member’s individual contract benefit, services are excluded when provided for the diagnosis or treatment of vision problems, including but not limited to the following:

Accommodating intraocular lens implants, in conjunction with cataract surgery or in the absence of cataracts, do not meet the definition of medical necessity when compared as an alternative to standard intra-ocular lenses.

BILLING/CODING INFORMATION:

See section entitled POSITION STATEMENT.

CPT Coding:

92071

Fitting of contact lens for treatment of ocular surface disease

92072

Fitting of contact lens for management of keratoconus, initial fitting

HCPCS Coding:

Q1004

New technology, intraocular lens, category 4 as defined in Federal Register notice

Q1005

New technology, intraocular lens, category 5 as defined in Federal Register notice

S0500

Disposable contact lens, per lens

S0504

Single vision prescription lens (safety, athletic, or sunglass), per lens

S0506

Bifocal vision prescription lens (safety, athletic, or sunglass), per lens

S0508

Trifocal vision prescription lens (safety, athletic, or sunglass), per lens

S0510

Non-prescription lens (safety, athletic, or sunglass), per lens

S0512

Daily wear specialty contact lens, per lens

S0514

Color contact lens, per lens

S0515

Scleral lens, liquid bandage device, per lens

S0516

Safety eyeglass frames

S0518

Sunglasses frames

S0580

Polycarbonate lens (List this code in addition to the basic code for the lens)

S0581

Nonstandard lens (List this code in addition to the basic code for the lens)

S0590

Integral lens service, miscellaneous services reported separately

S0592

Comprehensive contact lens evaluation

S0595

Dispensing new spectacle lenses for patient supplied frame

S0596

Phakic intraocular lens for correction of refractive error

V2530

Contact lens, scleral, gas impermeable, per lens

V2531

Contact lens, scleral, gas permeable, per lens

V2700

Balance lens, per lens

V2702

Deluxe lens feature

V2744

Tint, photochromatic, per lens

V2745

Addition to lens; tint, any color, solid, gradient or equal, excludes photochromatic, any lens material, per lens

V2756

Eye glass case

V2760

Scratch resistant coating, per lens

V2761

Mirror coating, any type, solid, gradient or equal, any lens material, per lens

V2762

Polarization, any lens material, per lens

V2781

Progressive lens, per lens

V2782

Lens, index 1.54 to 1.65 plastic or 1.60 to 1.79 glass, excludes polycarbonate, per lens

V2783

Lens, index greater than or equal to 1.66 plastic or greater than or equal to 1.80 glass, excludes polycarbonate, per lens

V2784

Lens, polycarbonate or equal, any index, per lens

V2786

Specialty occupational multifocal lens, per lens

V2787

Astigmatism correcting function of intraocular lens

V2788

Presbyopia correcting function of intraocular lens

V2797

Vision supply, accessory AND/OR service component of another HCPCS vision code

REIMBURSEMENT INFORMATION:

See section entitled POSITION STATEMENT.

Replacement for eye prostheses is limited to 3 within 12-months. Services in excess of this limitation are subject to medical review of documentation in support of medical necessity. The following information may be required documentation to support medical necessity: attending physician initial assessment, physician history and physical, and physician visit note.

LOINC Codes:

DOCUMENTATION TABLE

LOINC CODES

LOINC TIME FRAME MODIFIER CODE

LOINC TIME FRAME MODIFIER CODES NARRATIVE

Physician Initial Assessment

18736-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician visit note

18733-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determinations (NCDs) were reviewed on the last guideline reviewed date: Hydrophilic Contact Lens for Corneal Bandage (80.1), Hydrophilic Contact Lens (80.4), Scleral Shell (80.5), and Intraocular Lenses (IOLs) (80.12) located at cms.gov. No Local Coverage Determination (LCD) was found at the time of the last guideline reviewed date.

DEFINITIONS:

Aphakia: absence of the crystalline lens of the eye (e.g., after surgical removal of cataracts).

Enucleation: surgical removal of the eye.

Gas permeable scleral contact lenses (i.e., ocular surface prostheses): formed with an elevated chamber over the cornea and a haptic base over the sclera.

Intraocular lens: artificial lens that may be implanted to replace the natural lens after cataract surgery.

Keratopathy: any disease of the cornea.

Keratoconus: thinning of the cornea causing a cone-shaped bulging of the cornea, usually bilaterally; can by corrected by glasses, contact lenses, or surgery.

Pseudophakos: see intraocular lens.

Scleral shell (or shield): contact lens that fits over the entire exposed surface of the eye, opposed to corneal contact lenses that cover only the central non-white area (pupil and iris). When an eye has been rendered sightless and shrunken due to inflammatory disease, a scleral shell may, among other things, prevent the need for surgical enucleation and prosthetic implant, and acts to support the surrounding orbital tissue.

RELATED GUIDELINES:

Prosthetics, 09-L0000-05
Implantation of Intrastromal Corneal Ring Segments, 09-V0000-02

OTHER:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

REFERENCES:

  1. American Academy of Ophthalmology (AAO). Confronting corneal ulcers. 2012.
  2. American Academy of Ophthalmology Refractive Management/Intervention Panel. Refractive errors & refractive surgery. San Francisco (CA): American Academy of Ophthalmology; 2007.
  3. American Academy of Ophthalmology. Cataract in the adult eye. Preferred practice pattern. San Francisco (CA): American Academy of Ophthalmology (AAO); 2006.
  4. Blue Cross Blue Shield Association Medical Policy. Gass Permeable Scleral Contact Lens 9.03.25, Archived 9/2014.
  5. Medicare National Coverage Determinations Manual Chapter 1, Part 1, 80.1 Hydrophilic Contact Lens for Corneal Bandage, 09/14.
  6. Medicare National Coverage Determinations Manual Chapter 1, Part 1, 80.4 Hydrophilic Contact Lenses, 09/14.
  7. Medicare National Coverage Determinations Manual Chapter 1, Part 1, 80.5 Scleral Shield, 10/03.
  8. Medicare National Coverage Determinations Manual Chapter 1, Part 1, 80.12 Intraocular Lenses (IOLs), 10/03.
  9. National Institute for Health and Clinical Excellence (NICE). Implantation of accommodating intraocular lenses for cataract. Issue date: February 2007.
  10. National Institute for Health and Clinical Excellence (NICE). Interventional Procedures Program. Interventional procedure overview of the implantation of accommodating intraocular lenses during cataract surgery. Originally prepared August 2006.
  11. US Food and Drug Administration. Center for Devices and Radiological Health. PMA final decision for September 2004. P030002/S002. CrystaLens™ Model AT-45 Multipiece Silicone Posterior Chamber Accommodating Intraocular Lens (IOL).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/25/17.

GUIDELINE UPDATE INFORMATION:

11/15/01

Medical Coverage Guideline Reformatted.

10/15/03

Reviewed; no change in coverage statement.

01/01/04

Annual HCPCS coding update.

06/15/04

Unscheduled review with revision consisting of addition of non-coverage statement for “accommodating intraocular lens implants”; MCG name change.

10/01/04

4th Quarter HCPCS coding update; added S0515.

01/01/05

HCPCS coding update; added V2702.

04/01/05

2nd Quarter HCPCS coding update; added S0595.

01/01/06

Annual HCPCS coding update (deleted 92391 – 92396).

02/15/06

Revision consisting of removing V2628 (fabrication and fitting) from the list of codes describing prosthetic eyes.

06/15/06

Scheduled review (consensus) with revision consisting of removal of reimbursement statement regarding coverage of fabrication and fitting of prosthetic eye (V2628).

11/15/06

Revision consisting of adding clarification regarding reimbursement of prosthetic lenses and replacement lenses.

08/15/07

Reviewed; added V2788 to coding section; revised statement regarding accommodating IOL implants; reformatted guideline; updated references.

01/01/08

Annual HCPCS coding update: added V2787.

06/15/09

Scheduled review; no change in position statement; references updated.

11/15/09

Revision consisting of updating coding section (V2781 added).

01/15/10

Revision consisting of updating coding section (V2700 added).

06/15/10

Revision consisting of coding section update (Q1003 – Q1005, V2744, and V2760 added).

10/15/10

Revision; formatting changes.

01/01/11

Revision; related ICD-10 codes added.

04/01/11

2nd Quarter HCPCS coding update: Q1003 deleted.

06/15/11

Scheduled review; position statements unchanged; references updated.

07/01/11

Revision; formatting changes.

04/01/12

1st Quarter HCPCS coding update: S0596 added.

03/15/13

Revision: 66986 added.

05/15/14

Billing/Coding Information section updated; Program Exceptions section updated.

12/15/14

Revision to add criteria for gas permeable scleral lenses; updated Coding section; updated references.

11/01/15

Revision: ICD-9 Codes deleted.

10/15/16

Revision; billing/coding information section updated.

02/20/17

Update; Deleted ICD-9 codes 371.6-371.62 and 743.41.

06/15/17

Review; no change to position statement. Updated description, program exception and references.

Date Printed: August 23, 2017: 06:10 AM